TABLE 1.
Studies comparing SUBA-itraconazole with Sporanox in the fed and fasted statesa
| Study | No. of subjects | Single/multiple dose | No. of treatment periods per subject | Daily dosing (mg) per subject for: |
Sporanox source | Fed (yes/no) | Fasted (yes/no) | Replicate design (yes/no) | |
|---|---|---|---|---|---|---|---|---|---|
| SUBA-itraconazole | Sporanox | ||||||||
| MPG009 | 52 | Single | 4 | 1 × 65/2 periods | 1 × 100/2 periods | USA | Y | Y | N |
| HGN007b | 36 | Single | 4 | 1 × 50/2 periods | 1 × 100/2 periods | UK | Y | Y | N |
| HGN008b | 48 | Single | 4 | 1 × 50/2 periods | 1 × 100/2 periods | UK | Y | N | Y |
| 10850702 | 24 | Single | 4 | 1 × 50/1 period | 1 × 100/1 period | USA | N | Y | Y |
| 2 × 50c/1 period | 1 × 200/1 period | ||||||||
| 10850703 | 36 | Single | 4 | 1 × 50/2 periods | 1 × 100/2 periods | USA | Y | Y | N |
| 10850705 | 24 | Multiple | 2 | 2 caps × 50d q.d. × 15 days/1 period | 2 caps × 100d q.d. × 15 days/1 period | USA | Y | N | N |
| 10850706 | 24 | Multiple | 2 | 2 caps × 50e b.i.d. × 15 days/1 period | 2 caps × 100e b.i.d. × 15 days/1 period | USA | Y | N | N |
a
All studies were randomized crossover design studies with 2 or 4 treatment periods per subject.
b
Studies performed in the United Kingdom.
c
Two capsules were given at once as a single dose (total daily dose, 100 mg).
d
Two capsules were given at once as a single dose every day up to 15 days (total daily dose, 100 mg for SUBA-itraconazole and 200 mg for Sporanox). q.d., once daily.
e
Two capsules were given at once as a single dose twice daily (total daily dose, 200 mg for SUBA-itraconazole and 400 mg for Sporanox). b.i.d., twice daily.